Associate Site Manager - Mumbai/bangalore/hyderabad/delhi
Johnson & Johnson
Bangalore, Karnataka, India
Fully remote
Clinical trial protocol compliance
Good clinical practice (gcp)
Site initiation and close-out
This role serves as the primary contact point between the Sponsor and the Investigational Site, ensuring inspection readiness through compliance with protocols, SOPs, GCP, and applicable regulations
Job Summary
This role serves as the primary contact point between the Sponsor and the Investigational Site, ensuring inspection readiness through compliance with protocols, SOPs, GCP, and applicable regulations.
Responsibilities include assisting with site selection, initiation, monitoring (on-site and remote), and close-out activities, while partnering with the Local Trial Manager and other team members.
The Associate Site Manager will ensure site staff are trained, data entry and queries are resolved promptly, and all adverse events are reported within required timelines.
Matching Summary
This role serves as the primary contact point between the Sponsor and the Investigational Site, ensuring inspection readiness through compliance with protocols, SOPs, GCP, and applicable regulations.
Skills & Requirements
Must-have
Clinical Trial Protocol Compliance
Good Clinical Practice (GCP)
Site Initiation and Close-out
On-site and Remote Monitoring
Data Accuracy and Completeness
Nice-to-have
Process Improvement Contribution
Therapeutic Knowledge Development
Stakeholder Relationship Building
Risk-Based Monitoring Implementation
Key Requirements
2-4 years on-site monitoring experience
Bachelors Degree in life Sciences, Pharmacy, Medicine or related field